BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7600

    MDR report key: 2954099 · Received November 1, 2007

    Report

    Report Number
    9680959-2007-00132
    Event Type
    Malfunction
    Date Received
    November 1, 2007
    Date of Event
    October 9, 2007
    Report Date
    October 31, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE REP REPLACED THE IMAGE PROCESSOR ASM AND ALIGNED THE COLLIMATOR. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE 7600 SYSTEM WILL NOT BOOT. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1